A Phase II Non-blinded Randomized Study Comparing External Beam Radiotherapy (EBRT), 177Lu-PSMA-617, and Short Term Androgen Deprivation Therapy (ADT) Versus EBRT and Long Term ADT in Men With High Risk Localized Prostate Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Summary
This research is being done to find out if the study drug, 177Lu-PSMA-617, given before and during standard of care External Beam Radiation Therapy (EBRT) treatment, with a shorter course of Androgen Deprivation Therapy (ADT) (6 months) is (1) safe and effective compared to standard of care alone, and (2) can reduce the side effects caused by long-term (24 months) ADT in men with high risk localized prostate cancer.
Description
Men with high-risk localized prostate cancer include those with stage cT3a or Grade Group 4/5 or Prostate Specific Antigen (PSA) \>20 ng/mL, and the proportional rate of high-risk disease has increased to 20% of newly diagnosed patients in the US. These patients are currently recommended treatment with a combination of definitive radiotherapy and long-term androgen deprivation therapy (NCCN category 1) or radical prostatectomy with pelvic lymph node dissection. Radiotherapy most often consists of external-beam radiotherapy (EBRT) in 28 to 45 daily fractions with 1.5 to 3 years of ADT. Multiple…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Patient must have high-risk prostate cancer (HRPC) defined by presence of exactly one high-risk feature: cT3a OR Grade Group 4 or 5 OR PSA \> 20 ng/mL. * Histologic confirmation of adenocarcinoma of the prostate. * Patient must have localized HRPC defined by conventional imaging (no N1 disease by CT or MRI). Patients with or without intra-pelvic nodal metastases by PSMA-PET may be included as long as not enlarged \>10mm short axis by conventional CT size criteria. * Patients must have PSMA-PET (68Ga-PSMA-11 or 18F-DCFPyL) with prostate tumor SUVmax \> 10. * Patient must…
Interventions
- DrugEBRT + 6 mo ADT + 177Lu-PSMA-617
In Arm A, 177Lu-PSMA-617 will be given as intravenous infusion every 6 weeks, up to 4 cycles. Cycle 1 Day 1 (C1D1) of 177Lu-PSMA-617 will start at least 2 weeks after ADT, and EBRT will start at least 2 weeks after C1D1.
- RadiationEBRT + 24 mo ADT
In Arm B, EBRT will start 3-7 weeks after Day 1 of ADT.
Location
- Johns Hopkins UniversityBaltimore, Maryland